Keen2 Bracelet for Trichotillomania: An Open Trial

This study is testing a new way to help adults with trichotillomania (hair-pulling disorder) using a device called the Keen2 Predictive Awareness Bracelet. This bracelet, worn on your wrist, works with a mobile app to detect hand movements that might lead to hair pulling. It gives gentle vibrations to make you more aware of these movements. For eight weeks, you'll use the bracelet, and for the first four weeks, you'll also record information about your pulling episodes. In the last four weeks, the bracelet will give you personalized alerts to help you manage pulling. The study will look at how easy the bracelet is to use, how well people stick with it, and if it helps reduce hair pulling. We don't know the current recruitment status.

Study design
This is an open-label feasibility study, meaning everyone knows what treatment they are receiving. It involves about 10 participants and does not compare the bracelet to another treatment.
What's involved
You would wear the Keen2 bracelet and use its mobile app for eight weeks. During the first four weeks, you'd log information about your hair-pulling episodes.
Compensation
Not stated in the trial record.
Follow-up
Your hair-pulling severity will be measured at the start, at week 8, and again at week 12 after the study intervention ends.

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NCT07224126

Technology Assisted Treatment of Trichotillomania: Open Trial

Recruiting
NAAges 18+InterventionalTreatment
HabitAware Inc.
~10 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:Keen2 Predictive Awareness Bracelet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Trichotillomania Symptom Severity (NIMH-TSS)
Measured over Baseline, Week 4, and Week 8
Trichotillomania
1 sites across 1 states
Ohio1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

18 years of age (criterion 1a) with a diagnosis of TTM (criterion 1b)
Must reportEnglish as their primary language (criterion 2)
Report no current pharmacological or psychosocial intervention targeting TTM symptoms OR a6-week course of either intervention modality without change in frequency,intensity, or dosage (criterion 3)
Reliable and consistent access to the internet and/or mobile device permitting the participant to meet withsomeone virtually for 90 min.
Must report owning/access to a mobilephone running on Apple's operating system (iOS)
Identifies a support person that is able to be contacted is an emergency arises.
Agrees to allow the Kent State research team to share home address, mobile number, andalternate number/email with HabitAware, Inc., for purposes of mailing Keen2device and setting up Keen2 system.

Exclusion

Current suicidal/homicidal ideation, intent, or plan
a diagnosis of another psychiatric condition that may impeded a participant's ability to fully utilize the app (e.g., psychotic disorder, major depressive disorder)
  • Change in Trichotillomania Symptom Severity (NIMH-TSS)Baseline, Week 4, and Week 8

    The primary outcome is the change in total score on the NIMH Trichotillomania Symptom Severity Scale (NIMH-TSS) from baseline to week 8. The NIMH-TSS is a clinician-rated scale assessing the frequency, intensity, and distress associated with hair-pulling behavior. Higher scores indicate greater symptom severity. A reduction in score reflects improvement.